Pfizer Files NDA For Palbociclib In Breast Cancer With FDA
Pfizer announced that it has completed the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for its investigational drug palbociclib for the treatment of postmenopausal, treatment-naive women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.
Palbociclib is an oral targeted agent that works to selectively inhibit cyclin-dependent kinases (CDKs) 4 and 6 to restore cell cycle control and stop tumor cell spread. The FDA has granted Breakthrough Therapy status to the drug in April last year for the first-line systemic treatment of patients with advanced or metastatic ER+, HER2- breast cancer. The company is currently investigating the drug in other cancers aside from breast cancer through both Pfizer- and investigator-sponsored research.
The NDA submission was supported by the final results of a randomized Phase II trial PALOMA-1 comparing palbociclib with letrozole against letrozole as monotherapy in the patient group. The results show that the drug demonstrated a statistically significant, clinically meaningful improvement in progression-free survival (PFS) in women with advanced breast cancer. The trial’s final results were presented by the company at this year’s American Association for Cancer Research (AACR) Annual Meeting in April.
Garry Nicholson, President of Pfizer Oncology, said, “Today’s submission marks an important milestone for Pfizer and palbociclib, and a potential advance for women with advanced breast cancer.”
Breast cancer is the leading diagnosed cancer in women and the most common cause of cancer-related death among women around the world. ER+, HER2- is the largest molecular subgroup of the disease among post-menopausal women with advanced or metastatic breast cancer, representing an estimated 60 percent of cases. In spite of current available treatments, the survival rate of patients with metastatic or advanced breast cancer remains low.
The FDA will determine whether Pfizer’s NDA is satisfactory for filing within 60 days after which it will decide whether to accept Pfizer’s NDA.